Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA.
Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.

Code Information

Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.

Recalling Firm/Manufacturer

Abiomed, Inc.22 Cherry Hill DrDanvers, Massachusetts 01923

For Additional Information Contact

Michael O'hara 978-646-1543

Manufacturer Reasonfor Recall

Console shut down with no audible alarm

FDA DeterminedCause 2

PRODUCTION CONTROLS: Process Control

Action

Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device.
For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.